Mild Cognitive ImpairmentNCT06579378
Feasibility Study of Virtual Sail 3D in Cognitive Functions
A study testing VSail 3D and WEB-Health in people with Mild Cognitive Impairment, run by University of Cagliari at 1 site in Italy.
Trial summary
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- VSail 3D and WEB-Health
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: 65 years or older
- Sex: all
- Living independently,
- Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D,"
- Without severe issues with autonomous mobility
- With Mild Cognitive Impairment (MCI) according to Addenbrooke's Cognitive Examination for cognitive functions (ACE-R), which also includes the Mini-Mental State Examination (MMSE), with the following ranges: ACE = 66.93-79.86 and/or MMSE = 21-25.
- Signing the informed consent
Who cannot join
- severe cardiovascular conditions
- severe issues with autonomous mobility
- severe metabolic disorders not pharmacologically compensated
- severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.)
- severe ongoing bronchopulmonary disorders
- severe ongoing renal disorders
- glaucoma, retinal detachment, or other serious vision conditions that do not allow the safe use of 3D virtual reality technology
- active malignant neoplasm that do not allow the hinders participation in the intervention.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Cagliari
Cagliari, CA, 09124
Federica Sancassiani, Prof, 00393493119215, federicasancassiani@yahoo.it
About this study
Official title: Virtual Sail 3D - A Feasibility Study for Enhancing Cognitive Functions in Elderly People
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.
Read the detailed description
Research on active aging has been identified as a priority, particularly concerning the feasibility and effectiveness of non-pharmacological interventions aimed at preventing and/or delaying cognitive decline. Risk factors such as physical, cognitive, and social inactivity are estimated to account for about 40% of the risk of developing dementia in the lifetime. Recent reviews have shown that cognitive remediation interventions are effective in improving cognitive performance in older adults with and without cognitive decline.
Cognitive remediation is a behavior-based training intervention aimed at improving cognitive functions (memory, attention, executive functions, social cognition, and metacognition) to achieve lasting results and their generalization. There is substantial evidence supporting the effectiveness of such interventions in neuropsychological disorders such as dementia, mild cognitive impairment, and behavioral disorders.
In recent years, there has been an increase in the use of immersive 3D virtual reality software in clinical and rehabilitative settings as tools for rehabilitation and the improvement of various skills. To date, there are few studies where immersive 3D virtual reality is used to enhance cognitive functions related to personal and social functioning, especially to prevent cognitive decline in older adults (aged 65 and over).
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with sailing scenarious among elderly with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- VSail 3D, WEB-Health
- Keywords
- Virtual reality, Feasibility, Cognitive functions, Sail, Advances Technologies Laboratory
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSail 3DDevice
The "CEREBRUM" software with virtual sailing scenarios is made up of exercises of variable difficulty, designed to train different cognitive functions, in particular attention, memory, learning, cognitive estimates, working memory, executive functions, motor abilities and language. The different degrees of difficulty are designed to adapt to the user's functional diagnosis. The operator who conducts the intervention must adapt the difficulty level to the user's residual abilities, so that the exercises are neither too easy nor too complex. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback, and suggestions of practical homework related to the cognitive function trained during the session that the individual should try during daily life.
WEB-HealthOther
The intervention includes a series of 3 webinars focused on active ageing promotion. In particular, each webinar will regard topics related to healthy lifestyle, such as physical activity in old age, effective communication, stress management, technologies and health. Each webinar will be conducted by a mental health professional, and it will be delivered in real-time in a group (plenary).
| Study group | Role | What they receive |
|---|---|---|
| VSail 3D | Experimental | The "VSail 3D" experimental protocol includes 12 sessions (2 times a week, for 6 consecutive weeks) with scenarios (virtual environments) dedicated to the sport of sailing.
The duration of each session is 50-60 minutes. Receives: Device: VSail 3D |
| WEB-Health | Active comparator | The intervention regards education on healthy lifestyles to promote active ageing (topics: physical activity in old age; effective communication, stress management, technologies and health). It will consist of 3 seminars, delivered in the form of webinars, on a bi-weekly basis over 6 consecutive weeks, lasting 50-60 minutes each. Receives: Other: WEB-Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rates; Proportion of recruited participants among those considered eligible;
Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Simulator Sickness Questionnaire (SSQ)
Feasibility will be assessed based on side effects through the Simulator Sickness Questionnaire (SSQ), a self-report questionnaire that evaluates the frequency of unwanted effects that may occur due to the use of virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items.
The score range is 0-48, with higher scores indicating worse side effects.
Measured: T0 (0 weeks) - T1 (6 weeks)
Self-report satisfaction questionnaire
Feasibility will be assessed based on a Self-report satisfaction questionnaire, constructed ad hoc to evaluate the level of satisfaction with the program as a whole, the effect on psychophysical health, helping and listening abilities demonstrated by the operators, organizational support for activities, satisfaction with initial expectations.
The score range is 6-30, with higher scores indicating higher satisfaction.
Measured: T1 (6 weeks)
Secondary outcomes (8)
Trail Making Test
Preliminary measure of effectiveness on executive functions
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Digit Span
Preliminary measure of effectiveness on memory
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Stroop Test
Preliminary measure of effectiveness on executive functions
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Rey Figure Test
Preliminary measure of effectiveness on visual spatial function
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Frontal Assessment Battery (FAB)
Preliminary measure of effectiveness on executive functions
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Matrix test
Preliminary measure of effectiveness on selective attention
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Rey's Word Test
Preliminary measure of effectiveness on memory
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Addenbrooke's Cognitive Examination (ACE-R)
Preliminary measure of effectiveness on general cognitive functions, the neuropsychological tests is used to identify cognitive impairment in conditions such as dementia.
Measured: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione di Sardegna
- Responsible party
- Principal investigator, Federica Sancassiani, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579378
- Sponsor's protocol ID
- NP/2023/2557
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sancassiani F, Perra A, Vacca V, Montisci R, Monni M, Lorrai S, Cossu G, Petretto DR, di Natale L, Primavera D, Redolfi S, Scuteri A, Nardi AE, Kalcev G, Pau M, Carta MG. Enhancing Cognitive Functions in Older Adults With Mild Cognitive Impairment via Virtual Sail 3D: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 15;15:e85089. doi: 10.2196/85089.
PubMed 41538788
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Sail 3D - A Feasibility Study for Enhancing Cognitive Functions in Elderly People
- ClinicalTrials.gov ID
- NCT06579378
- Acronym / sponsor ID
- NP/2023/2557
- Conditions
- Mild Cognitive Impairment
- Keywords
- Virtual reality, Feasibility, Cognitive functions, Sail, Advances Technologies Laboratory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Fondazione di Sardegna
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with virtual sailing scenarios among elderly with mild cognitive impairment. CEREBRUM, developed by PRoMIND in association with IDEGO, is the first European tool for enhancing cognitive functions via 3D immersive virtual reality in psychosocial disabilities. Previous studies have shown its effectiveness in improving cognitive functions and well-being in people with bipolar disorders. The software includes modules for memory, learning, cognitive estimations, attention, working memory, and executive functions. For this study, the software was developed with sailing virtual scenarios to make it more enjoyable and engaging, as well as to train other cognitive functions such as motor skills and language abilities among people with disabilities.
Detailed description
Research on active aging has been identified as a priority, particularly concerning the feasibility and effectiveness of non-pharmacological interventions aimed at preventing and/or delaying cognitive decline. Risk factors such as physical, cognitive, and social inactivity are estimated to account for about 40% of the risk of developing dementia in the lifetime. Recent reviews have shown that cognitive remediation interventions are effective in improving cognitive performance in older adults with and without cognitive decline.
Cognitive remediation is a behavior-based training intervention aimed at improving cognitive functions (memory, attention, executive functions, social cognition, and metacognition) to achieve lasting results and their generalization. There is substantial evidence supporting the effectiveness of such interventions in neuropsychological disorders such as dementia, mild cognitive impairment, and behavioral disorders.
In recent years, there has been an increase in the use of immersive 3D virtual reality software in clinical and rehabilitative settings as tools for rehabilitation and the improvement of various skills. To date, there are few studies where immersive 3D virtual reality is used to enhance cognitive functions related to personal and social functioning, especially to prevent cognitive decline in older adults (aged 65 and over).
This research project will assess the feasibility and preliminary effectiveness of a 6-week intervention to improve cognitive functions using the 3D immersive virtual reality software "CEREBRUM" with sailing scenarious among elderly with mild cognitive impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| VSail 3D | Experimental | Device: VSail 3DThe "VSail 3D" experimental protocol includes 12 sessions (2 times a week, for 6 consecutive weeks) with scenarios (virtual environments) dedicated to the sport of sailing. The duration of each session is 50-60 minutes. |
| WEB-Health | Active comparator | Other: WEB-HealthThe intervention regards education on healthy lifestyles to promote active ageing (topics: physical activity in old age; effective communication, stress management, technologies and health). It will consist of 3 seminars, delivered in the form of webinars, on a bi-weekly basis over 6 consecutive weeks, lasting 50-60 minutes each. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age: 65 years or older
- Sex: all
- Living independently,
- Without conditions that would prevent them from participating in the activities of the experimental intervention "VSail 3D,"
- Without severe issues with autonomous mobility
Key exclusion criteria (8 listed)
- severe cardiovascular conditions
- severe issues with autonomous mobility
- severe metabolic disorders not pharmacologically compensated
- severe neurological conditions that prevent from participating in the experimental protocol, such as a stroke within the past 2 years, Parkinson's disease, epilepsy, or dementia (Alzheimer's, vascular, etc.)
- severe ongoing bronchopulmonary disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSail 3DThe "CEREBRUM" software with virtual sailing scenarios is made up of exercises of variable difficulty, designed to train different cognitive functions, in particular attention, memory, learning, cognitive estimates, working memory, executive functions, motor abilities and language. The different degrees of difficulty are designed to adapt to the user's functional diagnosis. The operator who conducts the intervention must adapt the difficulty level to the user's residual abilities, so that the exercises are neither too easy nor too complex. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback, and suggestions of practical homework related to the cognitive function trained during the session that the individual should try during daily life. | Device | VSail 3D |
| WEB-HealthThe intervention includes a series of 3 webinars focused on active ageing promotion. In particular, each webinar will regard topics related to healthy lifestyle, such as physical activity in old age, effective communication, stress management, technologies and health. Each webinar will be conducted by a mental health professional, and it will be delivered in real-time in a group (plenary). | Other | WEB-Health |
Primary outcome
Dropout rates; Proportion of recruited participants among those considered eligible;
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible.
Simulator Sickness Questionnaire (SSQ)
Time frame: T0 (0 weeks) - T1 (6 weeks)
Feasibility will be assessed based on side effects through the Simulator Sickness Questionnaire (SSQ), a self-report questionnaire that evaluates the frequency of unwanted effects that may occur due to the use of virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items. The score range is 0-48, with higher scores indicating worse side effects.
Self-report satisfaction questionnaire
Time frame: T1 (6 weeks)
Feasibility will be assessed based on a Self-report satisfaction questionnaire, constructed ad hoc to evaluate the level of satisfaction with the program as a whole, the effect on psychophysical health, helping and listening abilities demonstrated by the operators, organizational support for activities, satisfaction with initial expectations. The score range is 6-30, with higher scores indicating higher satisfaction.
8 secondary outcomes
Trail Making Test
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Digit Span
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Stroop Test
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Rey Figure Test
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Frontal Assessment Battery (FAB)
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Matrix test
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Rey's Word Test
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Addenbrooke's Cognitive Examination (ACE-R)
Time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 41538788Sancassiani F, Perra A, Vacca V, Montisci R, Monni M, Lorrai S, Cossu G, Petretto DR, di Natale L, Primavera D, Redolfi S, Scuteri A, Nardi AE, Kalcev G, Pau M, Carta MG. Enhancing Cognitive Functions in Older Adults With Mild Cognitive Impairment via Virtual Sail 3D: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 15;15:e85089. doi: 10.2196/85089.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSail 3D and WEB-Health in people with Mild Cognitive Impairment, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federica Sancassiani, Prof (00393493119215, federicasancassiani@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rates; Proportion of recruited participants among those considered eligible; (time frame: T0 (0 weeks); T1 (6 weeks); T2 (12 weeks from T1); T3 (24 weeks from T1); T4 (36 weeks from T1); T5 (48 weeks from T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.